Real-life comparison of efficacy and safety profiles of two prolonged-release tacrolimus formulations in de novo kidney transplant recipients: 24 months of follow-up

PLoS One. 2023 Jan 20;18(1):e0278894. doi: 10.1371/journal.pone.0278894. eCollection 2023.

Abstract

Introduction: Calcineurin inhibitors constitute a cornerstone of immunosuppressive therapy in kidney transplant recipients. There are two main formulations of tacrolimus (Tac) which exhibit a prolonged-release mode of action: Advagraf® (MR-4) and Envarsus® (LCPT). However, they are not bioequivalent. Data comparing both once-daily prolonged-release formulations of Tac are insufficient.

Objective: The aim of the study was to compare safety and efficacy profiles of once-daily LCPT and MR-4 formulations of tacrolimus in adult kidney transplant recipients.

Patients and methods: An observational, cohort single-center study was performed. One hundred fifteen kidney transplant recipients transplanted between 2016 and 2019 were enrolled to the study (59 vs 56, Envarsus® vs Advagraf®, respectively). Safety and efficacy profiles were assessed.

Results: Patient and graft survival at 12 and 24 months did not differ between the groups. There were no significant differences in serum creatinine at any timepoint. C/D ratio in the LCPT group was significantly higher at 12 and 24 months. Sepsis occurrence was more frequent in MR-4 group at 12 months.

Conclusion: Both prolonged-release formulations of tacrolimus are safe and effective in immunosuppressive therapy in kidney transplant recipients.

Publication types

  • Observational Study

MeSH terms

  • Adult
  • Delayed-Action Preparations
  • Follow-Up Studies
  • Graft Rejection
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Kidney Transplantation*
  • Tacrolimus* / adverse effects
  • Transplant Recipients

Substances

  • Tacrolimus
  • Immunosuppressive Agents
  • Delayed-Action Preparations

Grants and funding

The author(s) received no specific funding for this work.